Medical Devices Events

January 2017
Jan22
The Soundlink ,for hearing aid accessories (China) As the increasing attention for hearing loss,and giving birth to a variety of types and brands of hearing aids in the world To adapt the development of hearing aids,Soundlink try to develop kind of products,and provide best service to our clients.
Posted by Iris Peng on January 22, 2017
March 2017
Mar28
HIPAA Risk Assessment Best Practices (Fremont) The primary goal of this session is to demonstrate why the health care organization needs to perform a risk assessment and how to perform the risk assessment. #hipaa
Posted by Mentor Health on January 11, 2017
Mar28
HIPAA - and the Business Associate 2017 (Fremont) The objectives of this course will be to go over the specific risks associated with business associates as it relates to HIPAA compliance. #hipaa
Posted by Mentor Health on January 11, 2017
Mar28
Excel Formulas and Functions in Mastering (Fremont,CA,USA) Overview: Functions are built in formulas that have been programmed to perform a specific calculation. #Compliance4all
Posted by Shahanshah Manzoor on January 10, 2017
Mar29
HIPAA Risk Analysis 2017 (Fremont) This lesson is designed to enable your Organization to perform a complete Risk Analysis of all PHI it creates, receives, maintains or transmits in any format. #hipaa
Posted by Mentor Health on January 11, 2017
Mar29
Understanding Design Controls- By AtoZ Compliance (New Hyde Park) The design control plan – its contents, functions, uses, life cycle process and the FDA guidance on adaptive design #Adaptive Designs for Clinical Studies
Posted by AtoZ Compliance on February 21, 2017
Mar29
Risks associated with Elemental Impurities in cGMP Manufacturing (New Hyde Park) Risk management for corporate leader’s webinar for risk analysis and deviation resolution related to extractables and leachables #medicaldevicedesignprocess
Posted by AtoZ Compliance on March 2, 2017
Mar29
Balancing Customer Satisfaction With Security Issues (Fremont,CA,USA) Overview: This webinar is designed for professionals in every bank and credit union area to develop and maintain payments as the core business practice for their customers. #Compliance4all
Posted by Shahanshah Manzoor on January 10, 2017
Mar30
Design of Experiments (DOE) for Process Development (Los Angeles, CA) Prior to developing a process control plan as part of an overall risk management strategy, process development studies must be completed. The objective of these process development studies is to gain knowledge #GlobalCompliancePanl
Posted by Ronald Gardner on January 11, 2017
Mar30
Reinventing Remote Monitoring to Improve Clinical Trial Quality (New Hyde Park) Strategies for remote monitoring, review of data for trends & how to make the most of risk based monitoring #Improve Clinical Trial Quality
Posted by AtoZ Compliance on February 21, 2017
April 2017
Apr3
2017 Health Care Contracting Toolkit Best Practices (Fremont) This webinar will include a "Contracting Toolkit" of best practices that health care organizations can follow to avoid compliance traps related to the technical requirements for payments to physicians #healthcare
Posted by Mentor Health on February 14, 2017
Apr4
Inclusion of LGBT Employees in Healthcare: Navigating Policies (New Hyde Park) Healthcare is a unique culture dealing with vulnerable patients and employees committed to quality patient care. However, research states that LGBT patients are treated in a more abusive manner than straight patients.
Posted by Compliance Inc. on March 2, 2017
Apr4
Understanding Aseptic Technique and Clean room Behavior (New Hyde Park) Aseptic processing, facility design, environmental monitoring practices and how it impacts the product #fdacgmpcompliance
Posted by AtoZ Compliance on March 3, 2017
Apr4
What to Do When It's Not a Bell Curve? (Fremont) Overview: Statistical textbooks, manuals, and even most software rely on the assumption that processes conform to the normal or bell curve distribution. #Compliance4all
Posted by Dhananjay Agarwal on February 14, 2017
Apr4
Biologics Facility Design & Pharmaceutical Regulatory Aspects (Fremont) Overview: This course explores some of the best practices of pharmaceutical facility design with an emphasis on regulatory aspects. FDA and other global regulatory body requirements are discussed and the reasoning behind them. #Compliance4all
Posted by Dhananjay Agarwal on February 14, 2017
Apr4
How to improve the quality of their products by Statistical (Fremont) Overview: This webinar will be focusing on statistical process control as companies want to improve the quality of their products and to improve product quality need to be structured in such a way that they have a reasonable chance of success. #Compliance4all
Posted by Dhananjay Agarwal on February 14, 2017
Apr5
HIPAA and the Compliance Officer - By AtoZ Compliance (New Hyde Park) HIPAA compliance training on over 1000 risk assessments performed and the major changes under the Omnibus Rule #hipaachanges2017
Posted by AtoZ Compliance on March 14, 2017
Apr5
Preparation for GMP Inspections by Regulatory Agencies (Fremont) Overview: This webinar will provide practical tips and advice for ensuring that all inspections are conducted in the most effective and efficient way possible, including ongoing readiness for inspections. #Compliance4all
Posted by Dhananjay Agarwal on February 14, 2017
Apr6
Webinar on Medical Necessity: Can you define it (Fremont) This webinar will address the various methods of ensuring appropriate documentation to identify Medical Necessity for services provided. #medical
Posted by Mentor Health on February 14, 2017
Apr6
How to Develop HIPAA Policies and Procedures (Fremont) We will discuss the ongoing activities and also "Other Providers" audit activities, including methods on how to conduct internal monitoring for compliance. #Hipaa
Posted by Mentor Health on February 14, 2017
Apr6
Conference for Medical Device Manufacturing in HONG KONG (INTERCONTINENTAL HONG KONG) Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means
Posted by Ronald Gardner on January 30, 2017
Apr6
Employers Can Implement to Minimize the Risk of Workplace Violence (New York) Violence in the workplace is a subject employers need to address with policies, programs and procedures that prevent violence and mitigate harm when it occurs.
Posted by Compliance Inc. on March 7, 2017
Apr10
Webinar on Understanding Autism Spectrum Disorder (ASD) (Fremont) This webinar will provide evidence-based best practices for making sure students with Autism Spectrum Disorder (ASD) transition to college successfully and make the most of their educational experience. #healthcare
Posted by Mentor Health on February 14, 2017
Apr10
How to Develop HIPAA Policies and Procedures (Fremont) Attendees will leave the course clearly understanding of all the requirements for developing, maintaining and modifying HIPAA policies and procedures #Hipaa
Posted by Mentor Health on February 14, 2017
Apr10
How to Develop HIPAA Policies and Procedures (Fremont) Attendees will leave the course clearly understanding of all the requirements for developing, maintaining and modifying HIPAA policies and procedures #Hipaa
Posted by Mentor Health on February 14, 2017
Apr10
Water System Validation in Pharmaceuticals Industry 2017 (Hyderabad, Telangana) This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers
Posted by Ronald Gardner on January 30, 2017
Apr11
Webinar on HIPAA -and Personal Devices (online event) This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. #hipaa
Posted by Mentor Health on February 14, 2017
Apr11
A Comprehensive Guide to Navigating Ethics and Law. (New Hyde Park) Nowhere but in mental health are there more diverse clinicians providing the same or similar services of counselling and therapy. Various codes of ethics and state laws intersect to govern each mental health care practitioner.
Posted by Compliance Inc. on March 7, 2017
Apr11
Essentials of Complaint Handling and Medical Device Reporting (New York) Complaint management and Medical Device Reporting (MDR) are critical quality systems for you to meet the needs of your 3 key stakeholders – the customer, the regulators, and your business.
Posted by Compliance Inc. on March 7, 2017
Apr11
Effective Environmental Monitoring Program (New Hyde Park) Recent consent decrees have highlighted the importance that the FDA has put on environmental monitoring as a way of verifying control of the operational environment, along with the expectations when sampling methods yield positive results.
Posted by Compliance Inc. on March 13, 2017
Apr11
Export Requirements for FDA Regulated Products from the US to Foreign (New Hyde Park) This training will provide an in-depth explanation of FDA-Regulated Products that were exported from the United States to Foreign Countries.
Posted by Compliance Inc. on March 13, 2017
Apr11
How to Develop HIPAA Policies and Procedures - By AtoZ Compliance (New Hyde Park) HIPAA policies and procedures for conducting a self-assessment and security and risk analysis compliance audit #hipaacompliancetraining
Posted by AtoZ Compliance on March 13, 2017
Apr11
Acceptance Sampling by Variable inspections (Fremont) Overview: This presentation covers the methods in Z1.9 and shows how to use most common choice, standard deviation unknown. The presentation explains how a simple statistical calculator easily provides the needed sampling statistics. #Compliance4all
Posted by Dhananjay Agarwal on February 14, 2017
Apr11
Client Expectations Without Losing Your job (Fremont) Overview: By learning to present issues in the right framework we decrease adversarial behaviors on the project and increase the likelihood that our proposals for additional work will be accepted. #Compliance4all
Posted by Dhananjay Agarwal on February 14, 2017
Apr12
New HIPAA Audit and Enforcement Activities Webinar (online event,Fremont) In this session we will discuss the HIPAA audit and enforcement regulations and processes,and how they apply to HIPAA covered entities and business associates #Hipaa
Posted by Mentor Health on February 14, 2017
Apr12
Webinar on HIPAA Hot Topics and Current Trends (Fremont) This timely presentation delivers an update of the most important healthcare privacy and security rule / guidance regulatory changes, including but not limited to, HIPAA. #Hipaa
Posted by Mentor Health on February 14, 2017
Apr12
Monitoring a quality laboratory to prevent non-compliance (New Hyde Park) The use of statistical methods to assess and monitor certain variables and quality assurance activities of a quality laboratory to prevent non-compliance #exportingmedicaldevices
Posted by AtoZ Compliance on March 24, 2017
Apr12
1099-MISC:Block By Block Discussion (Fremont) Overview: This course will cover not only these common mistakes but make suggestions regarding the contents of each Block on the Form 1099-MISC. #Compliance4all
Posted by Dhananjay Agarwal on February 14, 2017
Apr12
Design Inputs Design Outputs Traceability Matrix (Fremont) Overview: If your design and manufacturing resources are spending too much time on documentation and not enough time on actual design and manufacturing you as a manager need to be looking for ways to simplify their work. #Compliance4all
Posted by Dhananjay Agarwal on February 14, 2017
Apr13
Injections vs Creams. Which is most effective? (Fremont) The positive side is immediate results the negatives consist of expense and discomfort although microneedles have mitigated the latter. #healthcare
Posted by Mentor Health on February 14, 2017
Apr13
FDA & CFIA 2016 Regulatory Changes/Updates -By AtoZ Compliance (New Hyde Park) FDA compliance and CFIA training in regulatory changes and updates in 2016 for all foreign food based businesses #fda and cfia regulatory compliance training
Posted by AtoZ Compliance on February 28, 2017
Apr13
How to Conduct a Human Factors - Test following ISO 62366 (Fremont) Overview: This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. #Compliance4all
Posted by Dhananjay Agarwal on February 14, 2017
Apr18
Medicare Part C & D Compliance Requirements Webinar (online event) We will discuss best practices for ensuring all criteria are met, documented and shared by the FDR's with their sponsors #compliance
Posted by Mentor Health on February 14, 2017
Apr18
Computer Systems Validations, Data Integrity (Hyderabad) This new 2-day Seminar on Computer Systems Validation provides participants with knowledge and tools to effectively use, monitor, control, and assure the integrity of electronic data and computerized systems. Seminar
Posted by Suzzane Dmello on January 30, 2017
Apr18
Introduction to Design of Experiments (New Hyde Park) Design of Experiments is a vital tool for process improvement and root cause analysis. It allows experimenters to determine beyond a quantifiable reasonable doubt that an experiment improves the process.
Posted by Compliance Inc. on March 14, 2017
Apr18
Course on Lean Documents, Lean Configuration and Document Control (New York) In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents.
Posted by Compliance Inc. on March 16, 2017
Apr18
Effective FDA and ISO Management Reviews (Fremont) Overview: In this presentation will cover the requirement for management review from FDA cGMP and ISO 13485 and approaches that can make these effective. Management review should be a key part of keeping your quality management system. #Compliance4all
Posted by Dhananjay Agarwal on February 14, 2017
Apr18
Packaging and Labelling for Clinical Products (Fremont) Overview: The program will review how to establish an effective artwork change management and approval system, including real-life examples of system successes and potential pitfalls. #Compliance4all
Posted by Dhananjay Agarwal on February 14, 2017
Apr18
Statistical Analysis of Measurement Uncertainty : Metrology (Fremont) Overview: The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios". #Compliance4all
Posted by Dhananjay Agarwal on February 14, 2017
Apr19
Understanding the USP 1058 Analytical Instrument Qualification (Fremont) Overview: Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA. #Compliance4all
Posted by Dhananjay Agarwal on February 14, 2017
Apr24
Webinar on Auditing Physician Contracts Under2017 Stark Rules (Fremont) Given the substantial awards and settlements in recent Stark Law enforcement actions, Stark Law compliance has become more than just a compliance issue: it is an enterprise risk management issue #audit
Posted by Mentor Health on February 14, 2017
Apr25
HIPAA Texting and Email with Patients (Fremont) This session will focus on the rights of individuals to communicate in the manner they desire, and how a medical office can decide what is an acceptable process for communications with individuals. #hipaa
Posted by Mentor Health on February 14, 2017
Apr25
How to Prepare a FDA 510(k) submission -By AtoZ Compliance (New Hyde Park) FDA 510(k) guidance, the procedure to prepare the submission, premarket notification for predicate device and substantial equivalence #FDA510ksubmission
Posted by AtoZ Compliance on February 14, 2017
Apr25
Analytical Method Validation in FDA process (Fremont) Overview: An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method. #Compliance4all
Posted by Dhananjay Agarwal on February 14, 2017
Apr25
Differences between ISO 13485 2015 v/s ISO 13485 2003 (Fremont) Overview: The webinar will first present the key differences between ISO 13485 2015 versus ISO 13485 2003.Next, the speaker will provide an overview of the updated standard. #Compliance4all
Posted by Dhananjay Agarwal on February 14, 2017
Apr25
Project Management Business Administration (Fremont) This course begins with general principles of Project Management Business Administration (PMBA) and continues to elaborate on specific topics relevant to pre-bid scenarios, execution phase strategies, and close out dilemmas. #Compliance4all
Posted by Dhananjay Agarwal on February 14, 2017
Apr25
Goldratt's Theory of Constraints (Fremont) Overview: This applied to his logistics system, which another reference depicted as a "continent spanning conveyor," but continuous flow in his factories achieved the same purpose at the manufacturing level. #Compliance4all
Posted by Dhananjay Agarwal on February 14, 2017
Apr26
2017 Webinar on HIPAA -Emailing and Texting (Fremont) This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. #Hipaa
Posted by Mentor Health on February 14, 2017
Apr26
Qualification of Clean Compressed Air Systems for cGMP Manufacturing (New Hyde Park) In the pharmaceutical industry, compressed air is used for a number of production and packaging applications, including blowing off and drying bottles prior to filling, conveying pills, providing air for pneumatically controlled valves
Posted by Compliance Inc. on March 22, 2017
Apr27
Regulatory Compliance by Implementing the Cost Effectively (Fremont) Overview: This webinar will introduce and overview the concept of containing compliance costs - working smart. The webinar will provide a comprehensive strategy for cost reduction in regulatory affairs and compliance by presenting strategies. #Compliance4all
Posted by Dhananjay Agarwal on February 14, 2017
Apr28
Measuring And Understanding Cognitive Overload And Human Error (New Hyde Park) Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented.
Posted by Compliance Inc. on March 24, 2017
Apr28
FDA Regulations for instrument Qualification (Fremont) Overview: In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions. #Compliance4all
Posted by Dhananjay Agarwal on February 14, 2017
May 2017
May1
10x Medical Device Conference (San Diego) 10x is your once annual chance to meet the members of the Medical Devices Group in person for networking, topical content, and ice cream! Now in its 5th year, it's highly rated by alumni. Give it a look. #10x
Posted by Joe Hage on December 30, 2016
May1
How to Meet FDA QSR and ISO 13485 Requirements - 2017 (Fremont) This presentation will review the QSR and ISO requirements for supplier evaluation and assessment. It will also provide cost efficient and equally compliant options for many of the most common practices in supplier management programs. #Compliance4all
Posted by Dhananjay Agarwal on March 17, 2017
May2
2017 Webinar on HIPAA Compliance for Dental Practices (Fremont) This webinar will cover the implementation specifications pertaining to administrative, technical and physical safeguards that must be in place under the Security Rule along with overall best security practices for PHI. #HIPAA
Posted by Mentor Health on March 15, 2017
May2
Promotional material compliance - 2017 (Fremont) The information obtained will enable effectiveness and reliability of a review process for all materials.The webinar will address requirements for compliance within the US, "gray areas" that must be evaluated thoroughly. #Compliance4all
Posted by Dhananjay Agarwal on March 17, 2017
May3
Webinar on MACRA Countdown (Fremont) In this session Mr. Wolfe will provide an overview of the Quality Payment Program, including its MIPS and Advanced APM pathways. #compliance
Posted by Mentor Health on March 15, 2017
May3
World Economies Cosmetic Regulations Webinar (Fremont) The EU's new Cosmetic Product Regulation (EU CPR) will be given a certain, wider position as the EU CPR is representing the latest, most modern regulatory framework which is influencing other global legislators. #Regulatory
Posted by Mentor Health on March 15, 2017
May3
Good Deviation Practice - CAPA Process - 2017 (Fremont) Overview: Attendees will have the opportunity to interact and ask questions about best practices regarding both devotions and the CAPA process. Reasons for having a robust deviation process are given with examples. #Compliance4all
Posted by Dhananjay Agarwal on March 17, 2017
May4
What you need to know for a truly effective internal audit program (Boston, MA) how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. #FDAAudit
Posted by Ronald Gardner on March 21, 2017
May4
2017 HIPAA Compliance (Boston, MA) This two day seminar takes the participants through HIPAA compliance from start to compliance. The presentations explain the history of HIPAA, why it came to being and its evolution. #HipaaCompliance
Posted by Ronald Gardner on March 21, 2017
May4
Modern HIPAA Compliance 2017 (Las Vegas, NV) Day one sets the stage with an overview of the HIPAA regulations including HIPAA Breach Notification and the process that must be used to determine whether or not a breach is reportable..... #HipaaCompliance
Posted by Ronald Gardner on March 21, 2017
May4
Laboratory, Medical and Device Performance and Validation (Boston, MA) This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts one uses when investigating quantitative ICH Guidelines . #MedicalDevice
Posted by Ronald Gardner on March 21, 2017
May4
Risk Management in R&D, QA/QC, and Manufacturing ( Houston, TX) The 2-day seminar explains how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. #RiskManagement
Posted by Ronald Gardner on March 21, 2017
May4
Medical Device Single Audit Program for Compliance Success (Boston, MA) Reviewing the most significant changes affecting medical device standards and guidance documents Understanding the MDSAP (goals and strategy) #MedicalDevice
Posted by Ronald Gardner on March 21, 2017
May4
Verification or Validation of Methods in Food Microbiology (New Hyde Park) Requirements for method validation and method verification in FDA CGMP compliance for labs in food microbiology #fdacgmpcompliance
Posted by AtoZ Compliance on March 17, 2017
May8
FDA using electronic health records - 2017 (Fremont) Overview: This webinar will discuss FDA's current recommendations on using electronic health records in prospective clinical investigations of human drugs, biologics, medical devices and combination product. #Compliance4all
Posted by Dhananjay Agarwal on March 17, 2017
May9
Webinar on HIPAA Audits (Fremont) I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (I’ve been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). #Hipaa
Posted by Mentor Health on March 15, 2017
May9
MedTech Commercial Leaders Forum USA 2017 (Princeton- New Jersey, USA) 4 EVENTS IN ONE: 1. MedTech Market Access, Reimbursement and Coding 2. Innovative Business Models for Devices and Diagnostics 3. Sales Force Effectiveness & Distributor Management for Devices 4. Multichannel & Digital Marketing for Medical Devices #nextlevelpharma
Posted by Lucia Kamhalová on January 31, 2017
May9
Tools for Human Error Reduction - 2017 (Fremont) Overview: Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. #Compliance4all
Posted by Dhananjay Agarwal on March 17, 2017
May10
Webinar on Recognizing and Responding to Personality Disorders (Fremont) This webinar will provide participants with the knowledge and skills they need to effectively meet the needs of this unique and growing population. #health
Posted by Mentor Health on March 15, 2017
May10
Understanding International ACH - 2017 (Fremont) Overview: Instructor will cover customer benefits and value proposition regarding International ACH and why it may be preferred over wire transfers. #Compliance4all
Posted by Dhananjay Agarwal on March 17, 2017
May11
Webinar on CMS CERT "Comprehensive Error Rate Testing" (Fremont) CMS oversees the CERT program. The objective of the CERT program is to estimate the accuracy of the Medicare FFS program by conducting improper payment measurements. #compliance
Posted by Mentor Health on March 15, 2017
May11
Webinar on HIPAA Enforcement Activity (Fremont) In this session we will review the HIPAA enforcement actions that have taken place and examine why the enforcement took place, and what could have been done to prevent the incident that led to the enforcement. #HIPAA
Posted by Mentor Health on March 15, 2017
May11
Developing Technical Training in the Life Sciences (SFO, CA) Developing Technical Training in the Life Sciences is a 2-day seminar that addresses the unique challenges of developing and managing training in Life Sciences companies. The Life Sciences pose unique challenges to training developers. #LifeSciences
Posted by Ronald Gardner on March 21, 2017
May11
Human Factors and Predicate Combination Products (Los Angeles, CA) The FDA has placed significant emphasis on the role of Human Factors in the approval of devices used for medical purposes. There are several current guidance documents and new proposed Draft Guidance documents. #MedicalDevice
Posted by Ronald Gardner on March 21, 2017
May11
Risk Management in Medical Devices Industry (Los Angeles, CA) Gaps, incorrect or incomplete implementation of software can delay or make the certification/approval of medical products impossible. #RiskManagement
Posted by Ronald Gardner on March 21, 2017
May11
Excel Spreadsheets - Step-By-Step Instructions - 2017 (Fremont) Overview: This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. #Compliance4all
Posted by Dhananjay Agarwal on March 17, 2017
May11
Implementing a Technology Transfer Process - 2017 (Fremont) Overview: It will cover the concepts associated with transferring the scientific technology needed to manufacture the product, processes to ensure the receiving manufacturing facility is ready for the product and tools and templates to help. #Compliance4all
Posted by Dhananjay Agarwal on March 17, 2017
May15
How FDA Trains its Investigators to Review CAPA - 2017 (Fremont) Overview: In this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection. #Compliance4all
Posted by Dhananjay Agarwal on March 17, 2017
May16
FDA Scrutiny of Promotion and Advertising - 2017 (Fremont) Overview: DTC may be deemed as misbranding your product and, therefore, may not be marketed. Firms must be more sophisticated now in designing their advertising methods and messages. #Compliance4all
Posted by Dhananjay Agarwal on March 17, 2017
May16
Phase I GMPs clinical trials - 2017 (Fremont) Overview: Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. #Compliance4all
Posted by Dhananjay Agarwal on March 17, 2017
May16
Conformal Cooling Conference (Minneapolis, MN) This conference is for management and technical personnel in OEM’s (Medical and other critical application industries), molding companies, and mold making companies to learn the facts about conformal cooling from the experts. #coolconf2017
Posted by Ronald Puvak on March 22, 2017
May17
Medical Device Employee Training - 2017 (Fremont) Overview: This is especially true for start-up and other small medical device companies, or rapidly growing companies. Specific FDA training requirements will be presented. #Compliance4all
Posted by Dhananjay Agarwal on March 17, 2017
May18
Webinar on 2017 Principles of IRB Review (Fremont) This webinar will discuss how IRBs can review research to fulfill the regulatory requirements as well as conduct appropriate and complete ethical review of research protocols. #compliance
Posted by Mentor Health on March 15, 2017
May18
Marketing, Advertising & Promotion ofPharmaceuticals&MedicalDevices (Chicago, IL) The changing game for drug and device marketing, however, is governed by antiquated and inadequate rules created for traditional print and broadcast advertising by the Food and Drug Administration ("FDA"). #MedicalDevice
Posted by Ronald Gardner on March 21, 2017
May18
Guidelines for New FDA Transfer of Analytical Methods - 2017 (Fremont) Overview: When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. #Compliance4all
Posted by Dhananjay Agarwal on March 17, 2017
May23
Webinar on Managing Risks Under HIPAA (Fremont) This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. #Hipaa
Posted by Mentor Health on March 15, 2017
May23
Webinar on Claims Adjustment Reason Codes (Fremont) By attending this CARC and RARC session, you will learn how to identify denials, understand the codes which affect your denials and ultimately establish effective and efficient processes to manage monitor and prevent denials. #audit
Posted by Mentor Health on March 15, 2017
May24
Webinar on How to Conduct a HIPAA Risk Assessment (Fremont) This webinar will cover concepts involved in a security risk analysis and overall risk management. Sample assessment questions will be reviewed and guidance provided on how to make risk level determinations based on responses #HIPAA
Posted by Mentor Health on March 15, 2017
May24
Root Cause Analysis to Meet FDA Expectations - 2017 (Fremont) Overview: Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis. #Compliance4all
Posted by Dhananjay Agarwal on March 17, 2017
May25
Webinar on New HIPAA Compliance Audit Program (Fremont) In this session we will discuss the HIPAA audit and enforcement programs and how they work, and discuss the areas that caused the most issues in prior audits. #HIPAA
Posted by Mentor Health on March 15, 2017
May25
Supplier Management in FDA- and ISO-regulated Industry ( Philadelphia, PA) upplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance. #FDA
Posted by Ronald Gardner on March 21, 2017
May31
Webinar on Off-Shore Business Associates (Fremont) The global Internet of Things and the HIPAA Privacy and Security Rules allow Protected Health Information (PHI) created by Covered Entities in the United States to be transmitted and stored outside the United States #HIPAA
Posted by Mentor Health on March 15, 2017
May31
Webinar on Quality Improvement in Human Research Protection Programs (Fremont) This webinar will discuss how implementing a targeted quality assessment and quality improvement program for a human research protection program and IRB can greatly improve efficiency, compliance, and consistently. #compliance
Posted by Mentor Health on March 15, 2017
MDMS, the Medical Device Marketing and Sales Workshop

10x Medical Device Conference

Events